MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SLCT,LD,NO NRS CLL, PNDNT RDY; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number N3A02BCEFMNP1

Device Problem Device Tipped Over (2589)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was inspected by the user facility but the issue was not confirmed; no defect or malfunction was found.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the bed tipped over.A patient fell, but no adverse consequences were reported.

• Brand Name: SLCT,LD,NO NRS CLL, PNDNT RDY
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• Manufacturer Contact: kaitlyn matheny ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 11236230
• MDR Text Key: 228926450
• Report Number: 3006433555-2021-00005
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: N3A02BCEFMNP1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1